Methods and apparatus for anchoring within the gastrointestinal tract

ABSTRACT

The present invention relates to an anchor configured for minimally-invasive implantation and sized to remain securely positioned within at least a portion of the gastrointestinal tract of an animal. The anchor includes a radial spring formed from an elongated resilient member shaped into an annular wave pattern about a central axis. The anchor defines a central lumen and provides an outward radial force, while allowing for substantial flexure about its perimeter. The anchor is generally removable, but can include fasteners, such as barbs, to further secure it to the surrounding anatomy. In some embodiments, the anchor includes a connector coupling a fixed portion to a removable portion. Further, the anchor can be used to secure a medical device within the body, such as a flexible sleeve within the intestine.

RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No.14/102,065, filed Dec. 10, 2013, which is a continuation of U.S.application Ser. No. 13/618,036, filed Sep. 14, 2012, now U.S. Pat. No.8,628,583, which is a continuation of U.S. application Ser. No.12/880,631, filed Sep. 13, 2010, now U.S. Pat. No. 8,303,669, which is acontinuation of U.S. application Ser. No. 10/858,852, filed Jun. 1,2004, now U.S. Pat. No. 7,815,589, which claims the benefit of U.S.Provisional Application No. 60/528,084, filed Dec. 9, 2003, and U.S.Provisional Application No. 60/544,527, filed Feb. 13, 2004. The entireteachings of the above applications are incorporated herein byreference.

BACKGROUND OF THE INVENTION

According to the Center for Disease Control (CDC), over sixty percent ofthe United States population is overweight, and almost twenty percentare obese. This translates into 38.8 million adults in the U.S. with aBody Mass Index (BMI) of 30 or above. The BMI is defined as a person'sweight (in kilograms) divided by height (in meters), squared. To beconsidered clinically, morbidly obese, one must meet at least one ofthree criteria: (i) BMI over 35; (ii) 100 lbs. overweight; or (iii) 100%above an “ideal” body weight. There is also a category for thesuper-obese for those weighing over 350 lbs.

Obesity is an overwhelming health problem. Because of the enormousstrain associated with carrying this excess weight, organs are affected,as are the nervous and circulatory systems. In 2000, the NationalInstitute of Diabetes, Digestive and Kidney Diseases (NIDDK) estimatedthat there were 280,000 deaths directly related to obesity. The NIDDKfurther estimated that the direct cost of healthcare in the U.S.associated with obesity is $51 billion. In addition, Americans spend $33billion per year on weight loss products. In spite of this economic costand consumer commitment, the prevalence of obesity continues to rise atalarming rates. From 1991 to 2000, obesity in the U.S. grew by 61%. Notexclusively a U.S. problem, worldwide obesity ranges are also increasingdramatically.

One of the principle costs to the healthcare system stems from theco-morbidities associated with obesity. Type-2 diabetes has climbed to7.3% of the population. Of those persons with Type-2 diabetes, almosthalf are clinically obese, and two thirds are approaching obese. Otherco-morbidities include hypertension, coronary artery disease,hypercholesteremia, sleep apnea and pulmonary hypertension.

Although the physiology and psychology of obesity are complex, themedical consensus is that the cause is quite simple—an over intake ofcalories combined with a reduction in energy expenditures seen in modernsociety. While the treatment seems quite intuitive, the institution of acure is a complex issue that has so far vexed the best efforts ofmedical science. Dieting is not an adequate long-term solution for mostpeople. Once an individual has slipped past the BMI of 30, significantchanges in lifestyle are the only solution.

There have been many attempts in the past to surgically modify patients'anatomies to attack the consumption problem by reducing the desire toeat. Stomach saplings, or gastroplasties, to reduce the volumetric sizeof the stomach, therein achieving faster satiety, were performed in the1980's and early 1990's. Although able to achieve early weight loss,sustained reduction was not obtained. The reasons are not all known, butare believed related to several factors. One of which is that thestomach stretches over time increasing volume while psychologicaldrivers motivate patients to find creative approaches to literally eataround the smaller pouch.

There are currently two surgical procedures that successfully producelong-term weight loss; the Roux-en-Y gastric bypass and thebiliopancreatic diversion with duodenal switch (BPD). Both proceduresreduce the size of the stomach plus shorten the effective-length ofintestine available for nutrient absorption. Reduction of the stomachsize reduces stomach capacity and the ability of the patient to take infood. Bypassing the duodenum makes it more difficult to digest fats,high sugar and carbohydrate rich foods. One objective of the surgery isto provide feedback to the patient by producing a dumping syndrome ifthey do eat these food products. Dumping occurs when carbohydratesdirectly enter the jejunum without being first conditioned in theduodenum. The result is that a large quantity of fluid is dischargedinto the food from the intestinal lining. The total effect makes thepatient feel light-headed and results in severe diarrhea. For reasonsthat have not been determined the procedure also has an immediatetherapeutic effect on diabetes.

Although the physiology seems simple, the exact mechanism of action inthese procedures is not understood. Current theory is that negativefeedback is provided from both regurgitation into the esophagus anddumping when large volumes of the wrong foods are eaten. Eventually,patients learn that to avoid both these issues they must be compliantwith the dietary restrictions imposed by their modified anatomy. In theBPD procedure, large lengths of jejunum are bypassed resulting inmalabsorption and therefore, reduced caloric uptake. In fact, thestomach is not reduced in size as much in the BPD procedure so that thepatient is able to consume sufficient quantities of food to compensatefor the reduced absorption. This procedure is reserved for the mostmorbidly obese as there are several serious side effects of prolongedmalabsorption.

Unfortunately, these procedures carry a heavy toll. The morbidity ratefor surgical procedures is alarmingly high with 11% requiring surgicalintervention for correction. Early small bowel obstruction occurs at arate of between 2-6% in these surgeries and mortality rates are reportedto be approximately 0.5-1.5%. While surgery seems to be an effectiveanswer, the current invasive procedures are not acceptable with thesecomplication rates. Laparoscopic techniques applied to these surgeriesprovide fewer surgical complications but continue to expose these veryill patients to high operative risk in addition to requiring an enormouslevel of skill by the surgeon.

Devices to reduce absorption in the small intestines have been proposed(See U.S. Pat. No. 5,820,584 (Crabb), U.S. Pat. No. 5,306,300 (Berry)and U.S. Pat. No. 4,315,509 (Smit)). However, these devices have notbeen successfully implemented.

SUMMARY OF THE INVENTION

One of the primary challenges in using medical devices to treat obesityis securing the device within the gastrointestinal tract. The naturallumens of the esophagus, stomach, and intestine provide relatively largediameters compared to the dimensions of delivery devices, such asendoscopes and/or catheters that are sized to minimize trauma to thenatural lumen. Further complicating matters are the natural muscularcontractions of that portion of the anatomy that subject devicesimplanted therein to substantial stresses and strains. Additionally,other forces such as gas bubbles within the intestine can compoundmatters by further increasing a local diameter of the intestine.

Thus, the combination of the large, varying diameters and muscularcontractions tend to dislodge devices implanted therein. Additionally,the natural peristaltic contractions of the intestine attempt to pushany device implanted therein either distally along with the normalpassage of chyme, or proximally due to retrograde contractions.

Non-surgical methods of implantation, such as endoluminal placement areattractive, but offer further challenges for inserting devicesconfigured to attach to such large-diameter lumens. These devices haveinstalled diameters of about 20 30 millimeters (mm) and are preferablyinserted through substantially smaller apertures. Minimally-invasivetechniques for accessing the gastrointestinal tract include insertionthrough natural body lumens (e.g., per-oral, per-rectal). Further, toreduce trauma to the lumen, the access channel is preferably smaller indiameter than the lumen itself. Thus, access to the intestine may belimited by the interior diameter of a working catheter, or about 12 mm.

The present invention solves these problems by providing an anchorconfigured for catheter-based implantation and sized to remain securelypositioned within at least a portion of the gastrointestinal tract,including the intestine. The anchor includes a radial spring formed froman elongated resilient member shaped into an annular wave pattern abouta central axis. Thus, the anchor provides an outward radial force, butallows substantial flexure about its perimeter. Such flexure isimportant to allow catheter-based delivery and to provide compliance,thereby ensuring that the device will conform to the surroundinganatomical structure.

The annular wave element defines a lumen along its central axis formedbetween two open ends of the anchor. When implanted, the central axis ofthe anchor is substantially aligned with the central axis of thegastrointestinal tract, allowing chyme to pass through the device.Additionally, the anchoring device minimizes trauma to the tissue byproviding sufficient flexibility and compliance, which minimizes thelikelihood of tissue erosion and yet provides a solid anchoring andsealing point in the tissue.

The anchor can be removably attached within the body using mechanicalfasteners such as barbs, surgical staples, and sutures and/or otherfasteners, such as surgical adhesives. In an alternative embodiment, theanchor includes a portion that is fixedly attached within the body. Aconnector can also be provided and configured to attach a removableportion to the fixed portion. At least one application includes thetreatment of obesity. Additional applications include the treatment ofintestinal disorders. For these applications, the anchor enables asleeve, or barrier, to be securely implanted within the intestine. Whenimplanted, the sleeve acts to block the uptake of food in that portionof the intestine and/or the triggering of normal hormone response tofood.

The invention relates to a gastrointestinal implant device including awave anchor compressible in a radial direction. The wave anchor isformed by an elongated resilient member about a central axis and definesa central lumen. The resilient member defines an oscillating patternbetween the first end and the second end of the device. The wave anchoris configured for insertion within a natural lumen of a gastrointestinaltract of an animal body. The central lumen can be the intestine, such asthe esophagus, the stomach, the duodenum, the jejunum, the ileum and/orthe colon.

In some embodiments, the oscillating pattern of the wave anchor has atleast four oscillations. Generally, the resilient member is formed froma metal, an alloy, a plastic, or combinations of these materials. Forexample, the resilient member can include a shape-memory alloy, such asa Nickel-Titanium alloy commonly referred to as Nitinol.

In some embodiments, the elongated resilient member includes a pluralityof strands. Moreover, some of the plurality of strands can havedifferent physical properties. More generally, the elongated resilientmember can include a first length having an associated physical propertyand a second length having a different associated physical property. Forexample, the physical property can be resiliency, thickness, and/orcross-sectional profile.

The central lumen of the wave anchor defines a diameter that is variablebetween a relaxed state and a compressed state. Also, an axial lengthseparates the first end and second end of the anchor. Notably, the ratioof the implanted axial length to diameter ratio is at least about one(e.g., 30×30 mm, or 40×40 mm). In a relaxed state (i.e., beforeimplantation) the length-to-diameter ratio can be as low as 0.8. In someembodiments, the relaxed diameter is about 45 mm, which compresses toabout 30 mm when implanted.

Further, the device can include a feature for securing the wave anchorwithin a natural lumen of the gastrointestinal tract. For example, thefeature can include an interference fit formed between the wave anchorand the natural lumen. Alternatively, or in addition, the feature caninclude a mechanical fastener, a chemical fastener, or combinationsthereof. Chemical fasteners include surgical adhesive; whereas,mechanical fasteners include barbs, sutures, staples, and combinationsthereof.

In some embodiments, the implant device is secured within the naturallumen using a number of barbs. These barbs can be arranged around one ofthe ends of the device. Further, the implant device can also be securedusing a number of barbs arranged around the same end, or the other endof the device. Generally, each barb includes an elongated member,attached at one end to the device with its other end extending away fromthe device being sized to engage muscular tissue of the natural lumen.In some embodiments, the barbs are bioerodible. Such bioerodible barbsare well suited for implantation as they serve to temporarily secure ananchor to the surrounding tissue. Then, after degrading, the anchor isfree to detach, and for intestinal applications, natural peristalsis canassist in removing the anchor from the body without the need for asecond surgical procedure.

The invention also relates to a method of treatment using anunsupported, flexible sleeve having a wave anchor coupled to itsproximal end. The sleeve is configured for implantation into a naturallumen of a gastrointestinal tract of an animal body.

Further, the invention relates to a gastrointestinal implant deviceincluding a first annular element configured for insertion into anatural lumen of a gastrointestinal tract of an animal, a fastener forfixedly securing the first annular element within the natural lumen, agastrointestinal implant, and a connector for removably coupling betweenthe first annular element and the gastrointestinal implant. The fastenercan be a mechanical fastener, a chemical fastener, and combinationsthereof. For example, the mechanical fastener can be one or more barbs,sutures, staples, and combinations thereof.

Additionally the gastrointestinal implant can include a second annularelement. The second annular element can include an elongated sleevehaving a proximal end and a distal end and defining a central lumentherebetween. The connector can be a clasp attached to one of the firstannular element and the gastrointestinal implant and configured forengaging a feature of the other of the first annular element and thegastrointestinal implant. Alternatively, or in addition, the connectorcan be actuated by magnetic attraction. For example, the connector caninclude a magnet attached to one of the first annular element and thegastrointestinal implant and configured for engaging a feature of theother of the first annular element and the gastrointestinal implant.

Still further, the invention relates to a process for implanting agastrointestinal device. The process includes inserting a first annularelement into a natural lumen of a gastrointestinal tract of an animal.The first annular element is then fixedly secured within the naturallumen. Next, a gastrointestinal implant is provided and removablycoupled to the first annular element. Notably, fixedly securing thefirst annular element can include providing a fastener, such as amechanical fastener, a chemical fastener, or combinations thereof. Forexample, the mechanical fastener can be a barb, a suture, a staple, orcombinations of any of these fasteners.

In some embodiments, the gastrointestinal implant includes a secondannular element, such as an elongated sleeve having a proximal end and adistal end and defining a central lumen therebetween.

Removably coupling can include providing a clasp, attaching the clasp toone of the first annular element and the gastrointestinal implant, andengaging with the clasp a feature of the other of the first annularelement and the gastrointestinal implant. Alternatively, or in addition,removably coupling includes providing a connector actuated by magneticattraction. The connector is coupled to one of the first annular elementand the gastrointestinal implant, and magnetically engages a connector afeature of the other of the first annular element and thegastrointestinal implant.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects, features and advantages of theinvention will be apparent from the following more particulardescription of preferred embodiments of the invention, as illustrated inthe accompanying drawings in which like reference characters refer tothe same parts throughout the different views. The drawings are notnecessarily to scale, emphasis instead being placed upon illustratingthe principles of the invention.

FIGS. 1A and 1B are respectively schematic diagrams of an end-view and aside view of one embodiment of the invention in a relaxed state;

FIG. 1C is a schematic diagram of a side view of the embodiment of theinvention illustrated in FIGS. 1A-1B in a compressed state;

FIG. 2A is a schematic diagram of a perspective view of the inventionillustrated in FIGS. 1A-1B;

FIG. 2B is a schematic diagram of a perspective view of an alternativeembodiment of the invention;

FIGS. 3A through 3D are schematic diagrams of exemplary alternativeembodiments of a wave pattern;

FIG. 4 is a schematic diagram of a side view of an embodiment of theinvention including an elongated sleeve;

FIGS. 5A-5C are schematic diagrams showing alternative types ofreinforcement of the embodiment of the invention shown in FIG. 4.

FIG. 6 is a schematic diagram of an embodiment of the inventionillustrated in FIG. 4 implanted within a natural lumen of agastrointestinal tract of an animal body;

FIG. 7 is a more-detailed cross-sectional diagram of one embodiment ofthe invention inserted within a natural lumen;

FIG. 8A is a more detailed schematic diagram of an embodiment of thebarbs illustrated in FIG. 7;

FIG. 8B is a more detailed schematic diagram of the tip of one of thebarbs illustrated in FIG. 8A;

FIGS. 8C-8D are schematic diagrams of insertion of the embodiment of theinvention illustrated in FIGS. 8A and 8B within a natural lumen;

FIG. 8E is a schematic diagram of an alternative embodiment of barbs;

FIG. 9 is a schematic diagram of a side view of an alternativeembodiment of the invention including sleeve barbs;

FIGS. 10A-10B are more detailed schematic diagrams of one embodiment ofsleeve barbs;

FIGS. 11A-11B are more detailed schematic diagrams of an alternativeembodiment of sleeve barbs;

FIGS. 12A-12B are more detailed schematic diagrams of yet anotheralternative embodiment of sleeve barbs;

FIG. 13 is a graph of representative compliance curves for differentembodiments of the invention;

FIGS. 14A-14B are schematic diagrams respectively of an embodiment of aconnector engaged, and engaging;

FIG. 15A is a perspective view of one portion of a magnetically-coupledwave anchor device;

FIG. 15B is a perspective view of a mating portion of themagnetically-coupled wave anchor device of FIG. 15A;

FIG. 15C is a side view of both portions of the magnetically-coupledwave anchor device shown in an uncoupled configuration;

FIGS. 15D and 15E are respectively a side and end view of amagnetically-coupled wave anchor device shown in a coupledconfiguration;

FIG. 16 shows one embodiment of the invention including barbs that areintegrally-formed; and

FIG. 17 shows an alternative embodiment of the invention including barbsthat are integrally-formed.

DETAILED DESCRIPTION OF THE INVENTION

A description of preferred embodiments of the invention follows.

The present invention relates to an anchor configured forminimally-invasive implantation and sized to remain securely positionedwithin at least a portion of the gastrointestinal tract of an animal.The anchor includes a radial spring formed from an elongated resilientmember shaped into an annular wave pattern about a central axis. Thus,the anchor provides an outward radial force, but allows substantialflexure about its perimeter. Such flexure is important to allowcatheter-based delivery (e.g., endoluminal) and to provide compliance,thereby ensuring that the device will conform to the surroundinganatomical structure.

When implanted, the central axis of the anchor is substantially alignedwith the central axis of the gastrointestinal tract allowing chyme topass through the device. Further, the device is resilient and sized tofit snugly within the intestine, yet compliant enough to allow theintestine to flex. Further, the wave pattern allows for radialcompression of the anchor by a substantial amount thereby allowing it tofit within a working channel of catheter. Still further, the anchorpresents a small surface area in contact with the intestine to minimizeirritation.

The anchor can be removably attached within the body using mechanicalfasteners such as barbs, surgical staples, and sutures and/or otherfasteners, such as surgical adhesives. In an alternative embodiment, theanchor includes a fixed portion fixedly attached within the body and aconnector configured to removably couple to a removable portion. Atleast one application includes the treatment of obesity and otherintestinal disorders. For these applications, the anchor enables asleeve, or barrier, to be securely implanted within the intestine. Whenimplanted, the sleeve can act to block the uptake of food for thatportion of the intestine covered by the sleeve.

Still further, the anchoring device is designed to minimize trauma tothe tissue by providing sufficient flexibility and compliance. Thus, theanchoring device minimizes the likelihood of tissue erosion, whileproviding a solid anchoring point in the tissue. In fact, it is possibleto vary the compliance of the anchoring devices quite readily by varyingat least one of the material, shape, and/or dimensions.

One embodiment of a device configured for insertion within a naturallumen of a gastrointestinal tract of an animal body is shown in FIGS. 1Aand 1B. The device includes a radial spring 100 including an elongatedresilient member formed about a central axis 115 and defining a centrallumen. The radial spring 100 has a first end 105 and a second end 110separated along the axis 115. Notably, the resilient member defines anoscillating pattern between the first end and the second ends 105, 110.In one embodiment, the radial spring 100 referred to generally as ananchor 100 includes a number of interconnected segments, legs, or struts120′, 120″ (generally 120). For example, the anchor 100 shown includesten legs 120.

Beneficially, the wave anchor implanted in a natural lumen adjusts tothe diameter of the surrounding anatomy. Exemplary relaxed diameter D₁can range from a substantial diameter of about 25 to 45 mm, representingthe size of an adult human's intestine. Advantageously, the radialspring is collapsible, capable of being compressed from the relaxeddiameter D₁ to an exemplary compressed diameter D₂ of about 12 mm, oreven less. Once inserted at a desired location within the natural lumen,the external force can be released, allowing the radial spring 100 toexpand to a deployed state. Ideally, the deployed diameter D₃ of theradial spring 100 is between the relaxed diameter D₁ and the compresseddiameter D₂, such that the radial spring 100 provides a biasing outwardforce against the natural lumen.

A schematic diagram of a side view of the embodiment of the invention ina compressed state is shown in FIG. 1C. As shown in the figures, thegeometry of the radial spring 100 lends itself to providing asubstantial ratio of the diameters between the relaxed spring state andthe compressed spring state. For example, this ratio of the diameterscan be substantial, such as 2-to-1 to greater than 3-to-1. Further, thetwo ends 105, 110 of the radial spring 100 are separated by a distanceL₁ in its relaxed state, and a slightly longer distance L₂ in itscompressed state. A minimum length of the anchor can be selected toprovide resistance to twisting, tending to keep the central axis of theanchor substantially aligned with the central axis of the natural lumenwithin which it is implanted. Further, a maximum length of the anchorcan also be selected to ensure that the anchor is no longer thannecessary, for example, to prevent blockage of the bile duct openingwhen implanted in the proximal duodenum. Exemplary relaxed lengths L₁can range from about 1 to 2 inches. In some embodiments, the L₁ isbetween about 1.25 and 1.5 inches. Additionally, the wave anchor can betapered so that one end is larger than the other end (e.g., the proximalopening is larger than the distal opening). Tapering in this mannerprovides some resistance to the device moving proximally and reinforcesengagement of any proximally-located barbs with the surrounding tissue.Thus, for an anchor implanted within the duodenum, the tapered profilewould resist the anchor from migrating through the pylorus and into thestomach.

The outward force of the radial spring can be controlled by thedimensions and material used. In some applications, the radial spring100 provides an anchor for securing a medical device within thegastrointestinal tract. For example, the anchor can be used for securinga feeding tube. In some applications, such as those intended forinsertion within an intestine, the dilation force is sufficient tomaintain the anchor 100 in communication with the lumen of the intestineat all times, yet not too great to cause substantial irritation to thesurrounding tissue. Further, the less dilation force of the anchor, theless likely the device will erode through the tissue.

The compliance of the anchor 100 is selectable depending upon the numberof nodes (pitch) and the diameter of the filament or wire used.Generally, the more nodes included in the oscillating pattern, the morecompliant the device will be. Additionally, the larger the filament orwire diameter, the less compliant the device will be. In someembodiments, such as laser-cut devices, both the width and thickness ofthe wire (e.g., rectangular profile) can be varied. Thus, the overallcompliance of the device is determined at least from the wave patternand the wire shape and/or diameter. In some embodiments, the radialspring uses 0.012-0.020 inches diameter wire and at least five nodes.

A perspective view of one embodiment of a wave anchor 200 is shown inFIG. 2A. A central lumen defined by the wave anchor 200 is aligned withthe z-axis 215. The wave pattern is generally formed along an imaginarycylinder residing at a predetermined radial distance from the z-axis215. The wave shape extends between maximum and minimum values along thez-axis 215. Notably, the wave anchor 200 can include a number of nodes,such as the five nodes illustrated. Generally, more than three nodes areused to define a central lumen. Also, as shown, the two ends of theelement forming the wave anchor 200 can be joined or otherwise coupledtogether at a joint 225. A weld, a bond, a mechanical crimp, aconstricting sleeve, and combinations thereof can be used to form thejoint 225.

The wave anchor 200 can be formed from a single filament, such as asingle strand of solid wire. Alternatively, the wave anchor 200 can beformed from a number of filaments, such as a multi-stranded wire.Additionally, the individual strands of the multi-stranded wire can beselected to have different physical properties (e.g., diameter,resilience). Thus, the overall compliance and resilience of the waveanchor 200 can be controlled by selecting and combining individualstrands having different properties. Further, the wave anchor 200 can beformed from a contiguous element forming the entire wave pattern(typically with one joint connecting two ends of an elongated member),or from a number of interconnected segments, together forming the wavepattern.

The wire and/or filaments can be made from any biologically compatibleresilient material. For example, the material can be a metal, an alloy,a plastic, and combinations of these materials. In some embodiments, thematerial is a spring metal, such as stainless steel. In otherembodiments, the material is an alloy. Preferably, the alloy is asuperelastic alloy capable of withstanding the application of largeforces and large movements and being able to recover from such largestrains.

One example of a superelastic alloy is Nickel-Titanium (NiTi) compoundcommonly referred to as Nitinol. In one particular embodiment, the waveanchor 200 is made from a single Nitinol wire having a diameter fromabout 0.012 inches to about 0.020 inches. As the dilation force may notbe sufficient to securely fasten the device to the local anatomy, someembodiments include anchoring features. For example, referring to FIG.2B, a number of anchors 250 are coupled to the wave anchor 200. Thus,the ability of the wave anchor is to remain securely fastened to thebody is enhanced by the addition of hooks and/or barbs 225.

FIGS. 3A through 3D are schematic diagrams of exemplary alternativeembodiments of a five-node wave pattern. In FIG. 3A, the wave pattern issinusoidal, extending along the z-axis between a maximum value ofone-half of the device length (i.e., +L/2) to a minimum value of minusone half of the length (i.e., −L/2). As indicated, the pattern is tracedover a radial distance of 2π radians along an imaginary cylinder havinga radius equal to half the diameter of the device (i.e., D/2). FIG. 3Billustrates an oscillating pattern formed by linear segments ofalternating pitch in which adjacent segments are joined together attheir ends by a curved segment. FIG. 3C illustrates a similaroscillating pattern formed by adjacent linear segments of alternatingpitch in which adjacent segments are joined together at their ends byexaggerated curved segments. Such exaggerated curved segments can reducethe stresses experienced at the ends of the device, thereby reducing thechances of material fatigue. Finally, referring to FIG. 3D, oneembodiment of the device includes a number of substantially linearsegments of alternating pitch in which adjacent segments are joinedtogether using a loop. The loop can be formed by bending the elongatedmember beyond π radians at the each of the nodes.

Advantageously, an anchor device formed from a wire is simple tomanufacture. For example, the device can be formed from a single Nitinolwire fashioned into any of the annular waves shown in FIGS. 2 and 3. Thetwo ends of the wire can be joined, or otherwise secured together toform a continuous wire structure. For example, the ends of the wire canbe joined together using a weld, a bond, a mechanical crimp, aconstricting sleeve, and combinations thereof. Notably, the shape,selection of materials, and construction of the device allow it to beradially compressed by a substantial amount without losing its originalshape and dimensions. For example, the device can accommodate a verylarge diameter D₁, such as the diameter of an adult human's intestine ofup to about 45 mm, while advantageously allowing it to be radiallycompressed, or packed into a delivery system having a smaller diameterD₂ of 12 mm or less. Also, the radial force provided by the device canbe controlled by the wire diameter from which it is made.

FIG. 4 is a schematic diagram of a side view of an embodiment of theinvention in which an anchor is attached to a medical device. In theexemplary embodiment, the medical device is an elongated sleeve. Asshown, the proximal end of the wave anchor 415 forms an annular ringhaving a wave-like shape formed about its perimeter. Preferably, thesleeve material proximal to the anchor 415 is cut back to match thisshape of the anchor 415 (e.g., forming a “tulip” shaped end). Such aconfiguration facilitates the formation of a seal at the proximal end ofthe sleeve 400 and also allows for independent movement with flexure ofthe anchor 415. Thus, proximal ends of the different “petals of thetulip” can flex independently as the sleeve material 410 does notrestrain them. Additionally, the tulip-shaped proximal end, wheninstalled, forms a secure seal along its entire perimeter when implantedin the gastrointestinal tract. Advantageously, such a tailored fitleaves no unsupported material between the edges of the device that foodcan get behind.

Generally, the proximal end of a sleeve device 400 is configured forreversible anchoring within the body. Notably, however, the sleevedevice 400 does not require significant dilation force, as it is notsupporting an opening into which it is placed (i.e., it is not a stent).Thus, the sleeve device 400 includes at least one anchoring, or securingdevice 415, attached to the sleeve 410. The purpose of the proximalsleeve anchor 415 is primarily to hold the sleeve 100 in place.Additionally, the anchor 415 provides some radial force to ensure thatthe sleeve 410 provides a fluid seal against the local anatomy. Such aseal is particularly important for intestinal applications. In theintestine it is desirable to constrain the flow of chyme within thelumen of the sleeve device 400, reducing or eliminating the likelihoodof chyme passing around the device. Beneficially, the propulsive forceof the stomach acts to push chyme into the device 400, ensuring thatmost of the chyme will enter the device.

As shown, the anchor device 415 can be fastened to the sleeve 410 at itsproximal end. The material can be attached to the anchor 415 bymechanical and/or chemical bonding, welding, and/or using othermechanical fasteners including sutures. In some embodiments the anchor415 is attached to the sleeve 410 by sandwiching it between an inner andouter layer of the sleeve 410. Thus, in some embodiments, the materialof the sleeve 410 extends around the radial exterior of the anchordevice 415. In this manner, the material can be folded back to a lengthL₂ measured from the proximal end of the device 400. Generally, thelength L₂ is greater than the axial extent of the anchor 415, L₁.Advantageously, the double layer of material 410 extends a distance L₃measured in a distal direction from the distal end of the anchor 415.The overlapping material 410 can be fastened together near the end ofthe overlap 420. For example, the two layers can be stitched togetheralong the line 420. Alternatively, the two layers can be chemically orthermally bonded together along the same line 420.

Generally, the sleeve is unsupported, having material propertiesselected to minimally irritate, or otherwise affect normal operation ofthe intestine. Thus, the material 410 is thin, light weight, supple andbiocompatible. For example, the sleeve 410 can be formed from anelastomeric material such as urethane and/or silicone rubber.Alternatively, the sleeve 410 can be formed from a substantiallynon-elastomeric material, such as a fluoropolymer and/or polyolefin.Some examples of fluoropolymers include PolyteTraFluoroEthylene (PTFE),expanded PTFE (ePTFE), Fluorinated Ethylene Propylene (FEP),PerFluoroAlkoxy (PFA), Ethylene TetraFluoroEthylene (ETFE), andPolyVinyliDene Fluoride (PVDF). Some examples of polyolefins includepolyethylene and polypropylene. The intestinal sleeve 410 is preferablythin-walled, unsupported and made of a flexible material that can becollapsed with minimal pressure from the outside. Thus, the unsupported,thin-walled material is naturally in a collapsed state and is openedonly by pressure formed within the lumen of the sleeve 410. In someembodiments, the thickness of the sleeve material is less than about0.001 inch. The sleeve is preferably formed from a low friction materialhaving a coefficient of friction of less than about 0.3. Morepreferably, the coefficient of friction is less than about 0.2. A lowcoefficient of friction facilitates insertion of the sleeve 410 within abody, and further facilitates passage of chyme therethrough.

Notably, as there is no network of struts with this design, the onlysubstantial force on the surrounding tissue is along the outer surfacearea of the wire itself. For example, a five-node sinusoidal wave anchorhaving a length L₁ of 1 inch, and a diameter D₁ of about 1.8 inchesformed from a 0.016 inches diameter wire provides a surface area ofabout 0.224 square inches. This results in a dramatic reduction in thesurface area of the tissue in contact with or otherwise affected by theanchor 415 (i.e., only the tissue in contact with the wire anchor),compared to typical, stent-type devices. It is therefore very unlikelythat the ampulla of Vater 124, which empties into the duodenum, would beblocked by this anchor when implanted within the upper intestine in thevicinity of the ampulla of Vater 124, even though the sleeve 410 extendsacross and beyond the ampulla of Vater 124. Longer and more stent-likedevices would be more likely to lie over the ampulla of Vater 124potentially blocking it. More generally, the sleeve can be anchored atother locations within the gastrointestinal tract. For example, theanchor can be placed in the stomach with the sleeve extending into theintestine. Alternatively or in addition the sleeve can be anchored inthe duodenum below the ampulla of Vater 124, or even in more distalportions of the intestine, such as the jejunum or ileum.

Such light-weight material is prone to reflux in the proximal direction.In some instances, the reflux results in a part of the material 410extending beyond the proximal end of the anchor 415. This situation isgenerally undesirable resulting from back pressure originating in thedistal intestine. Beneficially, the overlap described above providesadditional strain relief at the proximal end of the sleeve 410 to resistsuch reflux.

A cross-section of a portion of the proximal end of an unsupportedsleeve including a proximal anchor is shown in FIGS. 5A-5C. The proximalanchor 450 can be sandwiched between two layers of the sleeve material410. As shown, the proximal end of the sleeve 410 can be folded backupon itself, substantially enclosing the anchor 450 therein. An extendeddouble layer of the sleeve 455 can be continued for a predeterminedlength extending distally from the distal end of the anchor 450. Such adouble layer can provide additional strain relief. To secure the sleeveconfiguration, the two layers 410, 455 can be attached together. Forexample, the layers 410, 455 can be attached using sutures, staples,and/or chemical or thermal bonding 420. In an alternative embodimentshown in FIG. 5B, the sleeve 410 can be folded forming more than twolayers 455, thus providing even greater support and rigidity than thedouble layer. Still further, the sleeve 410 can be folded about asupporting member 460.

Referring now to FIG. 6, one embodiment of the invention is shownimplanted within a natural lumen of a gastrointestinal tract of ananimal body. In the exemplary implantation, an anchor 108 anchors anunsupported flexible sleeve 110 within the duodenum 106. In particular,the anchor is placed within the duodenal bulb 119, which is located justdistal to a pylorus 105. At least one advantage to anchoring in theduodenal bulb 119 is that there is relatively less motion compared toother parts of the duodenum 106. Further, the motion in the duodenalbulb 119 tends to be limited contractions, rather than contractions andlinear movements. Still further, the surrounding muscular tissue of theduodenal bulb 119 is relatively thick, thinning as one moves away fromthe pylorus 105, facilitating attachment of the anchor 108. The thicktissue is particularly advantageous in anchors using barbs.

At least one advantage resulting from anchoring at the duodenal bulb 106is that the pylorus 105 is allowed to open and close normally. Asdescribed above, the length of the anchor 108 is minimal to ensure thatthe ampulla of Vater 124 is not blocked. This distance in an averageadult human between the pylorus 105 and the ampulla of Vater 124 is atleast about 2 inches. Thus, the length of the anchor 108 is preferablyless than about 2 inches. Additionally, as described above a flare canbe provided at the proximal end of the anchor 108 functioning as a stopagainst the distal side of the pylorus 105 to resist reflux of thedevice 110 into the stomach 102. The flare also helps direct chymeflowing from the stomach 102 into the center of the anchor 108 andsleeve 110. Still further, the flare helps reinforce engagement of anyproximally-located barbs with the surrounding tissue.

FIG. 7 is a more-detailed cross-sectional diagram of one embodiment ofthe invention inserted within a natural lumen. Generally, the naturallumen 610 is formed within the interior of a hollow organ, such as theintestine 600. The cross-section of the intestine 600 includes a numberof different layers. For example, the intestine 600 includes muscularlayer 605 including muscular tissue for aiding in the passage of food.Additionally, the intestine includes a mucosal layer 615 along theinterior surface of the lumen. In the intestine, the mucosal layer 615is a mucosa layer formed of loose tissue. A gastrointestinal implant620, similar to the one shown in FIG. 4 is shown secured within theintestine 600. Thus the gastrointestinal implant 620 includes a waveanchor 630 coupled to the proximal end of an elongated sleeve 625. Theproximal end of the gastrointestinal implant 620 includes a number ofbarbs arranged in at least two layers: a proximal layer of barbs 640′,640″ (generally 640) located near the proximal end of the anchor 630;and a distal layer of barbs 645′, 645″ (generally 645). In someembodiments, the distal barbs 645 are located near the distal end of theanchor 630. In other embodiments, distal barbs 646′, 646″ (generally646) are located closer to the proximal end of the anchor 630 and caneven be just distal to the proximal barbs 640. As shown, the barbs 640,645 preferably penetrate the mucosa layer 615 extending into but notthrough the muscular layer 605.

In more detail, referring now to FIG. 8A, barbs 740, 745 can be attacheddirectly to the wave anchor 730. For example, one or more barbs 740, 745can be fastened to one or more of the legs or struts 730 of the waveanchor. The barbs 740, 745 can be fastened to the struts 730 by welding,bonding, or crimping means. Additionally, the barbs 740, 745 can befastened to the struts 730 using a mechanical fastener, such as a claspor splice 700. In some embodiments, the barbs 740, 745 can be formedcontiguous with the struts 730. Alternatively, or in addition, the barbs740, 745 can be molded onto the struts 730. For example, barbs can beformed by injection molding a first material onto the supporting struts730. The barbs can be injection molded onto a completely formed anchor730, and/or injection molded onto a substrate, such as a wire, that islater formed into the anchor 730. Such injection molding techniques arewell adapted to forming erodible barbs of a first material upon thesupporting anchor 730 formed from a second material, such as stainlesssteel or Nitinol. For example, the erodible barbs can be formed fromPolyLActide (PLA), PolyGlycolic Acid (PGA), and/or PolyparaDioxanone(PDS). Advantageously, depending on the configuration of the erodiblematerials, they can be formed to erode after a predetermined period ofimplantation. In some embodiments, a large number of barbs 740, 745(e.g., 80 barbs) are provided around the wave anchor.

In some embodiments, the barbs 740, 745 reside within a plane containingthe central axis of the anchor 730. Thus, the barbs extend outwardcontaining an axial component and a radial component, but not atransverse component. Alternatively, the barbs can extend outward fromthe central axis in a direction having a transverse component. Forexample, the barbs could reside substantially in a plane perpendicularto the central axis. Barbs having a transverse component can prohibittwisting of the anchor about its central axis.

The barbs 740, 745 can be fabricated from a shape-memory material, or asuperelastic material. For example the barbs can be formed from aNitinol wire having a diameter between about 0.016-0.025 inches. Thebarbs 740, 745 can also be formed from a rigid, yet resilient materialsuch as stainless steel. Preferably, the barbs 740, 745 are designed topenetrate into the surrounding intestine wall, but not through it.Accordingly, the length of the exposed barb 740, 745 is controlleddepending on the application. For example, for placement within theupper intestine, the barbs 740, 745 are approximately 3 mm long andextend outward from the device at an angle of about 45 degrees to aheight (i.e., penetration depth) of about 2 mm. This ensures that thebarbs 740, 745 penetrate the mucosa layer of the intestine and attach tothe underlying tissue.

The angle of each of the barbs 740, 745 can also be varied depending onthe desired effect. In some embodiments, proximal barbs 740 extend fromthe anchoring device 630 in a proximal direction; whereas, distal barbs745 extend from the anchoring device 630 in a distal direction. An angleis defined between the axis of each barb 740, 745 and the surface of thewave anchor. In some embodiments the distal barbs 745 form a first angleθ₁, while the proximal barbs 740 define a second angle, θ₂. In someembodiments, the first angle is a shallow angle, such as θ₁=10 degrees,while the second angle is substantially steeper (e.g., closer to 90degrees). In other embodiments, both angles are about 45 degrees. Inaddition to the angle, the barb heights h₁, h₂ control the respectivedepths of penetration into the surrounding tissue. For example forintestinal applications, a height of about 2 mm is preferred topenetrate into the muscular layer of the intestine without necessarilypuncturing the outer surface of the intestine.

A more detailed schematic diagram of the tip of one of the distal barbs745 is illustrated in FIG. 8B. Notably, the end surface of the barb 745can be fashioned with a predetermined profile. For example, the tip ofthe barb 760 can be blunt, tapered, and/or pointed. Additionally, thetip of the barb 760 can be directionally pointed, as shown. Thus, anangle formed between the axis of the barb 745 and its end surface area ais selected to provide a sharp profile along its leading edge 755 and ablunt profile along its trailing edge 760. Thus, movement of the distalbarb 745 in a proximal direction will not pierce the surface of thenatural lumen; whereas, movement in a distal direction will result inthe leading edge 755 tending to pierce the tissue of the natural lumen.Such a directional profile can aid in implanting the device at a desiredlocation. That is, the device can first be placed distal to the desiredlocation, then drawn proximally to the desired location and finallypushed distally again to set the distal barbs 745 into the tissue.

FIGS. 8C-8D are schematic diagrams of one the embodiment of theinvention being inserted within a natural lumen. Generally, duringimplantation, the distal barbs are set first. The compressed device isinserted into a predetermined location with the lumen and the distal endof the anchor is released allowing the distal barbs to come into contactwith the tissue of the lumen. Then, as described above, distal movementof the device along the axis of the lumen causes the distal barb 745 toinsert itself into the tissue 750. Once set, the proximal end of theanchor is released from its compressed state allowing the proximal barbsto pierce into the surrounding tissue 750. As the movement of the barbis substantially perpendicular to the surface of the lumen, the highangle results in the barb approaching the surface tissue at asubstantially perpendicular angle. Once implanted, the barbs 740, 745operate to secure the device to the surrounding tissue 750 resistingaxial movement along the lumen, and also securing the anchor duringradial expansion of the lumen.

To remove the anchoring device, it can be grasped at its proximal endand collapsed radially. Further, the radially collapsed anchoring deviceitself can be drawn into a sleeve or catheter for removal. Thus, theproximal barbs 740 being more vertical are easier to remove from thetissue 750 as the proximal end of the device is radially collapsed. Oncethe proximal end is collapsed, the device can be pulled proximallyallowing the distal barbs 745 to slide out of the tissue 750 due totheir lower angle. In some embodiments, the proximal and distal barbs740, 745 are formed having substantially the same angle.

In some embodiments, the barbs include hooks 770, 775 to grasp thetissue of the surrounding anatomy, such as those shown in FIG. 8E. Thehooks 770, 775 can be attached to one or more legs 730 of the anchor.For example, the hooks 770, 775 can be welded, bonded, or crimped to oneor more of the legs 730 of the device. As shown, the hooks 770, 775 canbe formed from a single filament of wire attached to one of the legs 730using a crimp sleeve 760. Thus, different materials can be used forhooks 770, 775 and the anchor itself. Alternatively, the hooks can beformed from different material, with each hook independently beingattached to the leg 730.

In some embodiments, the hooks 770, 775 are fabricated from ashaped-memory material, such as Nitinol wire. Preferably, theshaped-memory alloy is set for phase transition at around bodytemperature. Thus, the hooks 770, 775 can be cooled before insertion andconfigured in a substantially straight configuration to pierce thetissue of the surrounding anatomy. Then, when inserted into the tissue,a resulting raise in temperature to body temperature leads to a phasetransition resulting in the hooks 770, 775 re-shaping into hook-shape tograsp the tissue. For removal, the anatomy in the region of the hooks770, 775 can be cooled below body temperature, and below thephase-transition temperature to again straighten the hooks 770, 775thereby facilitating removal from the tissue. For example, the hooks770, 775 can be cooled with cold-water injection to soften the hooks770, 775 for installation and also for removal from the body. The hooks770, 775 can also be Nitinol, superelastic wires that are flattenedduring delivery and when released, they spring into the tissues.

If shape memory, they lay flat at room temperature to be collapsed foreasy insertion into the body. The hooks take shape at body temperatureto anchor into the tissue. If superelastic, they are forced flat andplaced in a tube for loading and the anchors spring to shape as they arepushed out of the delivery tube. FIG. 4C illustrates pre-deployed barbs.FIG. 4D illustrates deployed barbs and FIG. 4E illustrates the collapsedsystem for delivery.

FIG. 9 is a schematic diagram of a side view of an alternativeembodiment of the invention 900 including a wave anchor 920 coupled tothe proximal end of an elongated sleeve 910. In some embodimentssecuring devices 940′, 940″ are provided on the sleeve 910, notnecessarily at its proximal anchor 920. For example, as shown in FIG. 9,a sleeve device 900 includes a flexible sleeve 910 having a firstanchoring device 920, such as a wave anchor, at its proximal end. Insome embodiments, the wave anchor 920 can maintain its position withinthe gastrointestinal tract by relying on its radial force exerted uponthe surrounding tissue. Alternatively, the wave anchor 920 can includeone or more anchoring elements, such as a number of barbs 930 similar tothose described above in relation to FIGS. 8A-8E, to further secure theproximal end of the device 900.

Additional anchoring elements 940′, 940″ can be positioned along theflexible sleeve 910, separate from the wave anchor 920. For example,anchoring strips 940′, 940″ (generally 940) can be attached to thesleeve 910. Each anchoring strip includes one or more barbs. Forexample, a strip 940 can include multiple barbs linearly arranged alongthe strip 940.

FIGS. 10A-10B are more detailed schematic diagrams of one embodiment ofsleeve barbs 940. An anchoring strip 1000 includes a mounting frame 1010and a number of barbs 1020, each of the barbs 1020 coupled at one end tothe frame 1010. Preferably, the strip 1000 is compliant and flexible.For example, the strip 1000 can be formed from a thin strip of shapememory material, such as Nitinol, or stainless steel, having a thickness‘t’ selected to ensure the desired flexibility. In some embodiments, thebarbs 1020 can be attached to the mounting frame 1000 by mechanicalfasteners, welding, and/or chemical bonding. In other embodiments, thebarbs 1020 can be formed from the material of the strip 1000. Forexample, the barbs can be formed by cutting a shape, such as a triangleinto strip 1000, then bending the triangles outward from the strip, suchthat the barbs 1020 will engage the surrounding tissue when implanted.To ensure that the anchoring strip 1000 is flexible, the width of thestrip ‘W₁’, including the width measured from the edge of the strip 1010to the edge of the barb ‘W₂’ is controlled to a minimum distance.

In some embodiments, all of the barbs 1020 of a strip 1000 are orientedin the same direction to prevent movement in a one direction. In thismanner multiple anchoring elements 1000 can be mounted to a singlesleeve 910, with all of the anchoring elements 1000 providing barbs 1020substantially aligned in the same direction. Alternatively, theorientations of the multiple anchoring elements 1000 can be varied, suchthat some barbs 1020 are aligned in one direction, while other barbs1020 are aligned in another direction. In other embodiments, the barbsare formed substantially perpendicular to the surface of the strip 1010to prevent motion in either direction.

Alternatively, the barbs can be formed with different orientations onthe same strip as shown in FIGS. 11A and 11B. Thus, an anchoring device1100 includes a mounting strip 1110 containing a first barb 1120oriented in a first direction and a second barb 1130 oriented in adifferent (e.g., opposing) direction.

In other embodiments, as shown in FIGS. 12A and 12B, an anchoring strip1200 can be formed having a mounting strip 1210 formed from a moldablematerial, such as a polymer. In this manner, one or more barbs 1220 canbe attached to the mounting strip 1210 by including a portion that isanchored within the strip 1210 itself. For example, as illustrated, thebarbs 1220 can be formed from a segment of wire, such that a firstportion of the wire segment is embedded within the mounting strip 1210,while a second portion of the wire segment protrudes from the mountingstrip 1210, being adapted to engage the surrounding tissue whenimplanted.

An advantage of the wave design is the ability to form an anchor havinga very flat compliance curve over a very long range of diameters. Ingeneral, referring now to FIG. 13, exemplary compliance curves show theradial force exerted by different devices as they are radiallycompressed. This means that the force against the tissue issubstantially constant, even as the intestine contracts. Such acompliant device is less traumatic to the surrounding tissues. Exemplaryspring rates of the above-described wave anchors are an order ofmagnitude less than mesh-type stents. Additionally, the resulting springrates of the wave anchors are about half that of a typical Nitinol stentmade from tubing. Further, the range of motion of commercial stents isless than about 0.5 inches whereas the wave anchors can operate in arange of up to about 1.5 inches with a substantially flat compliancecurve. Exemplary test results are provided in Table 1 for known stentand for a number of other devices including wave anchors.

TABLE 1 Test Results Mesh-type Wave- Wave- Laser-cut Laser-cut Stent0.014 0.016 1 2 Spring Rate 1.714 0.0438 0.0722 0.168 0.253 (lbs./inch):(long) 0.240 (short) Approx. Range 0.3  1.0   1.0   0.5  0.35  (inches):

Depending upon the application, it may be necessary at times toperiodically remove the medical device (e.g., sleeve) from the body. Forexample, an intestinal sleeve may be periodically removed to provide arest period from material contact with the intestine, to adjust thetherapy with a longer or shorter sleeve, and/or to replace the sleevematerial before its useful life is over. Additional means to facilitateinsertion, removal, and reinsertion, a two-part anchor includes a firstportion fixedly attached within the body and a second portion adapted toremovably engage the first portion. Thus, the first portion or permanentanchor can be fixedly attached (i.e., implanted) within a patient. Thus,a permanent anchor can be fastened to the patient using mechanicaland/or chemical fasteners. Additionally, the permanent anchor can beconfigured to promote tissue in-growth to secure it within the body.

A second fastener can then be used to removably engage a medical deviceto the permanent anchor. For example, the second fastener can include aclip 1405 as illustrated in FIGS. 14A and 14B. Such a design enables amedical practitioner to easily fasten (e.g., “click”) the medical deviceinto and/or out of its position. Additionally, should a device, such asan intestinal sleeve become obstructed, it would be advantageous toallow the sleeve to dislodge itself and pass through the patient therebyavoiding potentially catastrophic consequences. Accordingly, in someembodiments, the fastening means release when the linear forces actingupon it increase sufficiently above a threshold to avoid harming thesurrounding tissue. Thus, the permanent anchor remains in place, whilethe fastening means are designed to break away at a predetermined force,such as about 2 lbs. Once the device breaks away, it can be withdrawn(e.g., through the esophagus), or can pass normally through the bowel,while the permanent anchor remains in place, ready to accept anotherdevice.

The clip, or clasp 1405 can be formed by a loop defined at least in partby a spring member 1410. The loop also includes an opening 1415 that canbe expanded by flexing the spring member 1410. Preferably the opening1415 is normally closed when the spring member 1410 is not being flexed.Thus, a feature of a mating device, such as the sleeve, can be insertedinto the clasp 1405, thereby securing the sleeve to the permanent anchor1400 as described above. For example, the proximal end of the sleeve caninclude or more loops 1420 such as loops formed by the nodes of a waveanchor. Upon removal, the one or more loops 1420 can be extracted fromthe clasp 1405 allowing the sleeve to be separated from the permanentanchor 1400 and removed from the body. The permanent anchor 1400 remainswithin the body and can be used again in a similar fashion. In analternative embodiment, the removable device includes one or more claspsconfigured to engage a feature, such as a loop, of the permanent anchor1400.

In an alternative embodiment of a two-piece anchor can be fastenedtogether using a magnetic fastener. For example, a permanent anchor canbe provided with one or more magnets. A second, removable anchor can beprovided with corresponding magnetically-attracted features configuredto attach to the one or more magnets of the permanent anchor. Thus, thepermanent and removable anchors are removably coupled together viamagnetic attraction. Alternatively, the removable anchor can be providedwith one or more magnets and the permanent anchor provided withcorresponding magnetically-attracted features, the two anchor removablycoupled together via magnetic attraction. Still further, each of thepermanent and removable anchors can be configured with both magnets andmagnetically-attracted features configured to magnetically couple withcorresponding features of the other anchor.

In one embodiment illustrated in FIGS. 15A-15E, a first anchor component1500 can be secured to an internal lumen of the gastrointestinal tractusing any of the above-described means. The first anchor component 1500includes a first and a second magnets 1505′, 1505″. The second anchorcomponent 1510 can be secured to a medical device, such as an elongatedsleeve. The second anchor component 1510 includes a first and a secondmagnetically-attracted feature 1515′, 1515″. The two anchor components1500, 1510 when brought into proximity with each other as shown in FIG.15C magnetically couple together as described above. A side view and anend view of the coupled anchors 1500, 1510 are respectively shown inFIGS. 15D and 15E.

In some embodiments, the wave anchor is formed from a wire or cablestrand. In other embodiments, as shown in FIGS. 16 and 17, the waveanchor can be cut from tubular stock. For example, the wave anchor canbe laser cut from a Nitinol tube. Advantageously, the wave pattern canbe formed so that a number of substantially identical wave anchors canbe cut from the same tube with minimal waste. Further, mechanicalfasteners, such as barbs or staples can also be cut from the same tube,so that the wave anchor and the barbs are contiguous. When formed inthis manner, the barbs would be bent or angled away from the axis of thewave anchor to engage muscular tissue as described above generally.

While this invention has been particularly shown and described withreferences to example embodiments thereof, it will be understood bythose skilled in the art that various changes in form and details may bemade therein without departing from the scope of the inventionencompassed by the appended claims.

What is claimed is:
 1. A gastrointestinal implant device comprising: an anchor configured to be retained within the duodenal bulb of a patient; a flexible sleeve configured to carry chyme from a proximal end of the flexible sleeve to a distal end of the flexible sleeve and adapted to extend into an intestine of the gastrointestinal tract, wherein the proximal end of the flexible sleeve is matched in shape to a proximal end of the anchor; and a connector removably coupling the proximal end of the flexible sleeve to the anchor.
 2. The gastrointestinal implant device of claim 1, wherein the connector comprises a magnet coupled to one of the anchor and the flexible sleeve and configured to magnetically engage a feature of the other of the anchor and the flexible sleeve.
 3. The gastrointestinal implant device of claim 1, wherein the connector comprises a connector magnetically coupling the flexible sleeve to the anchor.
 4. The gastrointestinal implant device of claim 1, wherein the flexible sleeve is configured to prevent flow of liquid across its membrane.
 5. The gastrointestinal implant device of claim 1, wherein the flexible sleeve has a terminal proximal diameter greater than a terminal distal diameter.
 6. The gastrointestinal implant device of claim 1, wherein the anchor is a wave anchor. 